Ability to Meet Enteral Nutritional Needs with a Peptide-based, High Protein Formula

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-01-31

Study Completion Date

2023-05-31

Brief Summary

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This is a prospective, open-label single-arm observational clinical trial to assess enteral feeding nutrition goals with a peptide-based, high protein enteral formula.

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Detailed Description

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This is a prospective, observational study to assess the ability to meet enteral nutrition goals and tolerance of a peptide-based, high protein tube feeding product in adult, tube-fed patients living in the community setting. In addition, the study will explore metabolic and inflammatory markers.

Conditions

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Enteral Feeding

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Prospective, single-arm, non-randomized, open-label observational study

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Enteral Tube-fed Adults

Adults being fed an enteral formula with a feeding tube

Group Type OTHER

Medical Food: Peptide-Based Enteral Formula

Intervention Type OTHER

Will be fed exclusively the study peptide-based, high protein enteral formula via a feeding tube

Interventions

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Medical Food: Peptide-Based Enteral Formula

Will be fed exclusively the study peptide-based, high protein enteral formula via a feeding tube

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Adults with established enteral access
* Anticipated to require enteral nutrition to provide 90% or more of their nutritional needs
* Signed informed consent

Exclusion Criteria

* Condition which contraindicates enteral feeding (i.e. intestinal obstruction)
* Any condition that would contraindicate use of the study product
* Patients with active colitis, radiation enteritis, SBS, undergoing active cancer treatment
* Judged to be at risk for poor compliance to the study protocol
* Participating in a conflicting clinical trial

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No